Arret 2 mg Hard Capsules

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Loperamide hydrochloride

متاح من:

PCO Manufacturing Ltd.

ATC رمز:

A07DA; A07DA03

INN (الاسم الدولي):

Loperamide hydrochloride

جرعة:

2 milligram(s)

الشكل الصيدلاني:

Capsule, hard

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Antipropulsives; loperamide

الوضع إذن:

Authorised

تاريخ الترخيص:

2005-11-28

نشرة المعلومات

_ _
_ _
ARRET
® 2 MG HARD CAPSULES
loperamide hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
–
This medicine is used to treat sudden short-lived (acute)
attacks of diarrhoea in adults and children aged 12 years and
over.
–
DO NOT TAKE THIS MEDICINE:
-
There are some people who should not use this
medicine. To find out if you are one of them.
See Section 2_ _
▶
-
If you are allergic to loperamide or any of the other
ingredients of this medicine.
–
SPEAK TO YOUR DOCTOR:
-
If you suffer from any of the conditions mentioned in
Section 2_ _
▶
-
If you are taking any other medicines. See Section 2
▶
–
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown
in the dosage table. See Section 3_ _
▶
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4
▶
•
You must talk to a doctor if you do not feel better or if you feel
worse after 24 hours.
WHAT IS IN THIS LEAFLET
1. What ARRET Capsules are, and what they are used for.
2. What you need to know before you take ARRET Capsules.
3. How to take ARRET Capsules.
4. Possible side effects.
5. How to store ARRET Capsules.
6. Contents of the pack and other information.
1.
WHAT ARRET CAPSULES ARE AND WHAT THEY ARE USED FOR
ARRET Capsules is a medicine which is used to treat sudden
short-lived (acute) attacks of diarrhoea in adults and children aged
12 years and over.
The capsules contain loperamide hydrochloride which helps
reduce diarrhoea by slowing down an overactive bowel, which
helps the body to absorb water and salts from the bowel. ARRET
Capsules should be used in conjunction with oral reh

خصائص المنتج

Health Products Regulatory Authority
05 April 2023
CRN00DHCV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arret 2 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 2 mg loperamide hydrochloride.
Excipient with known effect
Each capsule contains lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule
_Product imported from Greece_
Purple and green hard gelatin capsules containing a white powder.
4 CLINICAL PARTICULARS
As per PA0330/042/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/042/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Talc
Magnesium stearate
Titanium dioxide (E171)
Yellow ferric oxide (E172)
Indigotin
Gelatin
Erythrosine sodium
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Store in the original package.
Health Products Regulatory Authority
05 April 2023
CRN00DHCV
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 6 and 12 capsules contained in an outer cardboard
carton.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/155/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28 November 2005
Date of last renewal: 28 November 2010
10 DATE OF REVISION OF THE TEXT
April 2023